Kornimate/medical-research-clean huggingface dataset:
acetylcysteine against acute renal insult during cardiopulmonary bypass.

Conditions: Cardiovascular Disease; Renal Insufficiency, Acute; Cardiopulmonary Bypass

Summary: the purpose of this study is to determine whether n-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.

background reactive oxygen species have been shown to cause contrast-induced nephrotoxicity (cin). according to previous studies, the n-acetylcysteine has been proved to be advantageous in the avoidance of cin. we seek to evaluate the efficacy of the antioxidant n-acetylcysteine in limiting the nephrotoxicity after cardiovascular surgery with cardiopulmonary bypass. methods we will prospectively study 60 patients who will receive a cardiovascular surgery with cardiopulmonary bypass. patients will be randomly assigned to receive either n-acetylcysteine (600 mg orally twice daily for 4 doses) with 0.45% saline intravenously, before and after cardiopulmonary bypass, or placebo with 0.45% saline. serum creatinine and blood urea nitrogen will be measured before, 48 h and 5 days after the operation procedure. expected results prophylactic oral administration of the antioxidant n-acetylcysteine, along with hydration, will significantly reduce the acute renal damage induced by cpb in patients with chronic renal insufficiency that need cardiovascular procedures.

Eligibility criteria:
inclusion criteria: * all patients who will received cardiac surgery with cardiopulmonary bypass exclusion criteria: 1. dialyzed patients 2. acute renal failure 3. advanced left ventricular systolic dysfunction defined as left ventricular ejection fraction ≦ 35%. 4. acute chronic obstructive lung disease or asthma exacerbation 5. allergy to n-acetylcysteine

Keywords: acetylcysteine cardiac surgery cardiopulmonary bypass acute renal insufficiency
vascular healing after bvs-implantation

Conditions: Coronary Heart Disease

Summary: evaluation of coronary artery vessel wall healing at different time points in patients undergoing implantion of bioresorbable vascular scaffold by using intravascular imaging. in addition long-term clinical follow-ups are planned for all patients treated with absorb in the institution

oct-guided evalutation of the coronary vessel wall, endovascular healing and bioresorbable vascular scaffolds at different time points. these results will be analysed in terms of clinical presentation, gender and age.

Eligibility criteria:
inclusion criteria: * optical coherence tomography examination after bvs-implantation exclusion criteria: * none

Keywords: bioresorbable vascular scaffold optical coherence tomography strut coverage acute coronary syndrome
mycoplasma genitalium infection and associated antimicrobial resistance among hiv-infected male in hong kong

Conditions: STI; Mycoplasma Genitalium Infection

Summary: worldwide, mycoplasma genitalium (mg) is increasingly reported as an emerging cause of sexually transmitted infections. internationally, the prevalence of mg is higher in male with urethritis and community groups especially among people living with hiv (plhiv). while mg is treatable, antimicrobial resistance is a rising concern. this cross-sectional study aims to determine the prevalence of mg infection and the antimicrobial resistance pattern in hiv-infected male in hong kong. a total of 750 hiv-infected male attending hiv specialist clinic in hong kong would be recruited. the main outcome measures include prevalence of mg and resistance mutations to macrolide/fluoroquinolone in hiv-infected male; prevalence of mg/sti co-infections, as defined by concurrent detection of mg and one or more other bacterial sti.

a total of 750 hiv-infected male attending hiv specialist clinic in hong kong would be recruited. an online questionnaire would be self-administered. the participants would self-collect urine sample, rectal and pharyngeal swabs for mg, chlamydia trachomatis (ct) and neisseria gonorrhoeae (ng) screening by nucleic acid amplification tests, and mg genotypic resistance mutations detection. clinical data would be transcribed from medical records of recruited subjects.

Eligibility criteria:
inclusion criteria: * aged 18 or older, male, hiv-infected, and are attendees of the hiv specialist clinic, and can communicate in written and spoken english or chinese exclusion criteria: * not able to provide consent

Keywords: chlamydia trachomatis mycoplasma genitalium infection neisseria gonorrhoeae men who have sex with men heterosexual men people living with hiv
evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery

Conditions: Colectomy

Summary: evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery

single-centre prospective randomised study carried out in two parallel groups of patients undergoing laparoscopic colectomy. * group 1: conventional general anaesthesia with morphine * group 2: general anaesthesia without opiates

Eligibility criteria:
inclusion criteria: * patient over 18 years of age who has read and signed the consent form for participation in the study * patient candidate for laparoscopic colectomy (planned or emergency) with possible conversion to laparotomy exclusion criteria: * severe renal failure with baseline clearance\<30, hepatic failure with baseline pt\<40%, cardiac failure with lvef\<20%. * patient under court protection, guardianship or curatorship * pregnant or breastfeeding patient * patient not affiliated to the french social security system * impossible to give the subject informed information and/or to give written informed consent: dementia, psychosis, disturbed consciousness, non-french speaking patient * contraindication to anaesthesia or to the administration of one of the products used in the anaesthesia protocol * patient participating in another interventional research or in a period of exclusion from a previous research
the effect of vinegar consumption on visceral fat and blood glucose concentration

Conditions: Visceral Obesity; Tooth Erosion; Insulin Resistance

Summary: the purpose of this study is to test the potential ability of vinegar to significantly decrease visceral fat in healthy adults with "central obesity". during the 8-week trial, participants will either consume a low-dose vinegar pill (control treatment) or a vinegar drink twice per day. research aim and hypothesis h1 daily vinegar consumption will be associated with loss in visceral fat (as measured by dxa) after 8 weeks compared to the placebo treatment (low-vinegar pill) in a group of healthy adults with "central obesity". h2 daily vinegar consumption will be associated with a decrease in abdominal circumference after 8 weeks compared to the placebo treatment (low-vinegar pill) in a group of healthy adults with "central obesity".

this randomized, placebo-controlled experimental trial will last 8 weeks. at the initial visit (consenting visit lasting about 20 minutes) the participant will sign the consent and complete a short health questionnaire and a short questionnaire on tooth erosion. body height and weight and waist circumference will also be measured. qualifying participants will be stratified by gender, age, weight, and waist circumference, then randomized into two groups: the intervention group, vinegar drinks (vin) or the control group, vinegar pills (con). the participants will know which treatment they are given but they will not know which group (control vs. placebo) they are in. those who receive the vin will be instructed to drink 2 tablespoons of red wine vinegar (provided) mixed with water twice each day for weeks 1 to 8 of the trial. those in the con group will be instructed to take one vinegar pill (provided) each day for weeks 1-8 of the trial. participants will be instructed to maintain their current diet and exercise habits during the study.

Eligibility criteria:
inclusion criteria: * nonsmoking * not pregnant or lactating if female * no active disease state or medication use affecting blood glucose or cholesterol (additionally, individuals on digoxin or diuretics will be excluded but other medications in use \>3 months will be allowed) * no food restrictions or special diet * bmi range: 22-35 * waist circumference \>34 (women) and \>39 (males) * sedentary (exercising \< 3 days/week) exclusion criteria: * unwilling to take a vinegar supplement daily for 8 week or follow other aspects of study protocol * recent abdominal surgery or condition causing abdominal discomfort/distention (such as acid reflux, ascites, pancreatitis, diverticulitis/diverticulosis, crohn's disease, and/or irritable bowel syndrome)

Keywords: randomized clinical trial vinegar adiposity insulin resistance
preventing prescription drug abuse in middle school students

Conditions: Prescription Drug Abuse (Not Dependent); Substance Use; Substance Abuse

Summary: this project is designed to test a primary prevention approach to the problem of prescription drug misuse and abuse (pda) among middle school students. the intervention uses both online e-learning and small group facilitator-led intervention modalities. middle schools will be randomized to receive the intervention or serve as controls.

while there are a number of drug abuse prevention programs for middle school age youth, relatively few programs focus on preventing prescription drug abuse. furthermore, due to growing constraints on classroom time, new evidence-based prevention programs are needed that flexibly incorporate the use of online digital technology and classroom/small-group components. the present study is developing and testing an adaptation of the evidence-based substance abuse and violence prevention approach called life skills training (lst). the proposed preventive intervention for middle school pda will (1) utilize both online digital and face-to-face intervention modalities to address pda and concurrent atod use; (2) positively change social norms and challenge positive expectancies regarding pda and atod use; (3) discourage diversion of prescription medications; and (4) enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios. middle schools will be randomized into either an intervention group that will receive the new intervention or a treatment-as-usual control group that will receive existing health education programming. at the end of the intervention period, and at a 12-month follow-up assessments, we will compare both groups with respect to changes in behaviors, norms, attitudes, and knowledge regarding pda and substance use.

Eligibility criteria:
inclusion criteria: * middle school aged-youth exclusion criteria: * significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
post-market clinical evaluation of the spiracur snap wound care system for treatment of acute trauma and acute surgical excision wounds

Conditions: Trauma-related Wound; Surgical Wound, Recent

Summary: the purpose of this study is to evaluate the efficacy of the spiracur snap® wound care system for the treatment of acute trauma and acute surgical excision wounds. the secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.


Eligibility criteria:
inclusion criteria: * trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities * wound \< 16 cm in greatest diameter * subject ≥ 18 years of age * exudate \< 25 ml/ day (estimate) * female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study * subject is willing and able to sign informed consent exclusion criteria: * wound \> 45 days old * wound-related cellulitis * wound located in an area not amenable to forming an air-tight seal * subject has untreated osteomyelitis * subject is allergic to wound care products * wound has exposed blood vessels not suitable for negative pressure therapy * subject is pregnant * subject is actively participating in other clinical trials that conflict with current study * subject has fistulas
comparative effectiveness and safety between warfarin and dabigatran

Conditions: Atrial Fibrillation

Summary: this is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. there is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in japan.

this is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. there is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in japan.

Eligibility criteria:
inclusion criteria: * patients aged \>18 year-old with confirmed diagnosis of non-valvular atrial fibrillation (nvaf) (icd 10 code i48) * having a first prescription (index date) of either dabigatran or warfarin between 14 march 2011 to 30 june 2016 * having no prescription of any oral anticoagulants (oacs) for 12 months prior to the index date (this period is defined as the baseline period) exclusion criteria: * patients having less than 12 months of enrolment prior to the index date * being dialysis or kidney transplant recipients in baseline period * having either atrial flutter, valvular atrial fibrillation (af) * mechanical valve placement, rheumatic af * and/or mitral valve prolapse/regurge/stenosis in baseline period * having record of deep vein thrombosis or pulmonary embolism \< 6 months before af diagnosis in baseline period
a study of hr071603(ketamine nasal spray) in healthy subjects

Conditions: Depression

Summary: the study is being conducted to evaluate the safety and pharmacokinetics of hr071603 in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. obtain informed consent prior to the start of any activity related to the trial, and have a thorough understanding of the purpose and meaning of the trial and be willing to comply with the protocol; 2. healthy males aged between 18 and 45 (including both ends); 3. weight ≥ 50kg, body mass index (bmi) in the range of 18.5 \~ 23.9 (including both ends); 4. during the trial and within 30 days after the administration, willing to take contraceptive measures and ensure that no sperm is donated. exclusion criteria: 1. a subject considered by the investigator to be unsuitable for nasal spray administration; 2. allergic to any component of the study drug; 3. the underlying disease is not suitable for participation in the trial; 4. 12-lead ecg results in the screening period are abnormal and clinically significant 5. liver dysfunction; 6. serum creatinine \> 1.2 × uln during screening period; 7. screening for infectious diseases screening hepatitis b surface antigen (hbsag), hepatitis c antibody (hcvab), syphilis antibody, human immunodeficiency virus (hiv) antibody test positive; 8. subject has been thoroughly examined, and the results are abnormal and clinically significant; 9. major operations were performed within 3 months before the screening period. 10. donate whole blood/plasma within one month before the screening period, or donate whole blood/plasma more than 400 ml within three months before the screening period; 11. positive urine drug test; 12. the alcohol breath test is positive; or the average daily intake of alcohol exceeds 15g; 13. nicotine test is positive; 14. history of drug abuse or alcohol abuse; 15. in the past three months, over five cups of coffee or tea per day were consumed in an average; 16. any prescription drugs, over-the-counter drugs and health products were used within 2 weeks before screening. 17. participated in clinical trials of any drug or medical device within 3 months before screening ; 18. any other medical or psychological condition, which in the opinion of the investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements, or to complete the study.
a study of onset of action of loratadine and fexofenadine in participants with seasonal allergic rhinitis (p08712)

Conditions: Rhinitis

Summary: the purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (loratadine and fexofenadine) in a model of seasonal allergic rhinitis (sar). participants undergo sensitization exposures to mountain cedar (juniperus ashei) pollen in a biogenics research chamber; those who demonstrate an adequate allergic response determined by the major symptom complex (msc) score will then receive drug.


Eligibility criteria:
inclusion criteria: * female participants of child bearing potential must demonstrate a negative urine pregnancy test at screening (visit 1) and visit 4 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the screening visit and throughout the study. * willing to stop use of current decongestant and allergy medications at the start of the washout period (visit 1) and during the trial. * documented history or participant-reported history of seasonal allergic rhinitis caused by mountain cedar pollen within the last 2 years and documented or participant-reported symptoms over at least the last 2 mountain cedar allergy seasons. * documented skin testing (prick with wheal ≥ 4 mm larger than the diluent) within the last 1 year to mountain cedar pollen present. * capable of reading english. * body mass index (bmi) \<35. exclusion criteria: * any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, fexofenadine or might interfere with the trial. these may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy. * have started allergen immunotherapy within 1 month preceding enrollment or participants starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. xolair (omalizumab) may not be used within 4 years prior to trial participation. * known allergy or intolerance to loratadine, desloratadine, or fexofenadine. * history of rhinitis medicamentosa. * use of systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone is permitted), or nasal corticosteroids in the last 30 days or current or expected use of disallowed medications as listed in the protocol. * asthma, with the exception of mild intermittent asthma.
moderate alcohol intake among patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes.

successful long-term control of hyperglycemia decreases the risk for diabetic complications . although a family history of diabetes is an established risk factor for type 2 diabetes, lifestyle factors also play an important role in its cause . however, physicians are poorly informed about how their patients' alcohol use affects risk for or management of diabetes. moderate alcohol consumption has been associated with lower risk of both cardiovascular disease and type 2 diabetes, and is also linked to lower cardiovascular risk among type 2 diabetics. potential mechanisms have focused primarily on lipid metabolism, coagulation, fibrinolysis, and insulin sensitivity. a recent systematic review of the literature to assess the effect of alcohol consumption on risk for and management and complications of diabetes mellitus suggests that moderate alcohol consumption is associated with a decreased risk for diabetes, whereas heavy alcohol consumption may be associated with an increased risk. our aim is to assess the effect of moderate alcohol intake on glycemic control and cardiovascular disease mediators among patients with type 2 diabetes.

Eligibility criteria:
inclusion criteria: 1. age between 40-75 yrs. 2. alcohol abstainers (less than or equal to 1 drink/week) 3. established diagnosis of type 2 diabetes. 4. clinically stable, with no stroke or mi within the last 3 months and no major surgery within the last 3 months. exclusion criteria: 1. taking insulin \>2 injections /day, or with insulin pump. 2. tgs\>500 mg/dl. 3. hba1c \>10% 4. serum creatinine \> 2 mg/dl 5. liver dysfunction (above 2 fold level of alt and/or ast enzymes) 5. evidence of severe diabetes complications (such as proliferative retinopathy or renal disease). 6. patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness. 7. using drugs that might significantly interact with moderate alcohol. list of drugs will be obtained from pharmacology expert. 8. presence of active cancer, receiving or had received chemotherapy in last 3 years. 9. suffering a major illness that might probably require hospitalization (upon physician's evaluation). 10. clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse. 11. severe symptoms during run-in as assessed by the physician. 12. pregnant or lactating women. 13. participation in another trial in which active intervention is being received. -

Keywords: adherence glycemic control